BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUREVAC CHEST DRAINAGE SYSTEM SAHARA DRYSUC

    MDR report key: 2043487 · Received February 25, 2011

    Report

    Report Number
    3004365956-2011-00073
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A NURSE IN THE ICCS NOTICED AN AIR LEAK THAT WAS AT THE CONNECTOR SITE. NO OBVIOUS DEFECT WAS SEEN. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUREVAC CHEST DRAINAGE SYSTEM SAHARA DRYSUC PLEUREVAC CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL NA 02D1002413

    Patients

    Seq Age Sex Outcome Treatment
    1